When the specimen is added into the test device, the specimen is absorbed into the device by capillary action, mixes with the SARS-CoV-2 antigen-dye conjugate and flows across the pre-coated membrane.

SAMPLE TYPE: Whole Blood/Serum/Plasma

When the SARS-CoV-2 antibodies level in the specimen is at or above the target cutoff (the detection limit of the test), the antibodies bound to the antigen-dye conjugate are captured by anti-human IgG antibody and anti-human μ chain antibody immobilized in the Test Region of the device, and this produces a colored test band that indicates a positive result.

When the SARS-CoV-2 antibody level in the specimen is zero or below the target cutoff, there is not a visible colored band in the Test Region (T) of the device.

This indicates a negative result.To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly.

This test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2 and provides preliminary test results.

Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decision.

COVID-19 RNA RAPID DETECTION KIT(PCR-Fluorescence Probing)

This kit is based on one-step RT-PCR technique. In practice, 2019 Novel Coronavirus (2019-nCoV)ORF1ab and N genes are selected as amplification target regions. Specific primers and fluorescent probes are designed for the detection of 2019 Novel Coronavirus RNA in the specimens.

This kit also includes an endogenous internal standard detection system, which is used for monitoring over the processes of specimen collection, RNA and PCR amplification, thereby reducing false negative results.

This kit is used for the in vitro qualitative detection of novel coronavirus (2019-nCoV) ORFlab and N gene in the throat swabs, sputum specimens of suspected pneumonia patients infected by novel coronavirus, suspected clustering cases and others needing diagnosis or differential diagnosis for novel coronavirus.

Detection of novel coronavirus RNA shall meet the requirements of related guideline, clinical diagnostic/disease control and other documents, so as to carry out the regulations on biosafety.

The detection results of this kit are for clinical reference only and should not be used as the sole criteria for clinical diagnosis. It is recommended to conduct a comprehensive analysis on the condition in combination with the clinical manifestations of the patient and other laboratory tests.